Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
NCT ID: NCT00197392
Last Updated: 2013-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
434 participants
INTERVENTIONAL
2004-11-30
2010-01-31
Brief Summary
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Detailed Description
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B-EVD is manufactured using a patented process to impregnate silicone catheters with two antibiotics, rifampin and clindamycin. These antibiotics are impregnated throughout the silicone matrix. After implantation, slow release of both antibiotics at the extra- and intra-luminal catheter surfaces minimizes the likelihood of bacterial colonization. The B-EVD Catheter System has, to date, been well accepted by domestic and European customers. Currently there exists sound scientific rationale and promising bench-top in vitro data to anticipate low levels of ventriculostomy-related infection in Subjects using this system. Published BACTISEAL shunt data and direct feedback from U.S. market experience also support this notion. There are no published clinical studies reporting infection rates with the use of the B-EVD System, making all statements regarding its propensity to minimize clinical risk for catheter-related infection mere speculation and anecdotal. Therefore, Codman proposes to undertake a controlled clinical evaluation of this product to demonstrate its influence on EVD catheter-related infections, using a conventional EVD catheter as a standard of reference.
Immediately following successful screening, the Subject will be randomized to test or control group and will have the appropriate EVD system implanted. The Treatment Phase will cover the duration of the implanted EVD system. Subjects will be monitored for 2 weeks post-explant.
This study is expected to enroll 600 evaluable implanted Subjects at up to 15 Investigational Sites in US, Europe and Asia-Pacific
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bactiseal TM EVD
Bactiseal External Ventricular Drainage System.
Bactiseal TM EVD
Standard of care implantation of external ventricular drainage catheter
Standard EVD Catheter
Standard External Ventricular Device system
Standard EVD Catheter
Standard of care EVD system other than Bactiseal.
Interventions
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Bactiseal TM EVD
Standard of care implantation of external ventricular drainage catheter
Standard EVD Catheter
Standard of care EVD system other than Bactiseal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The Subject (family member/legal representative) has given written Informed Consent prior to enrollment into this trial OR, where the Subject is unable to consent and no relative/legal representative is available to offer consent, appropriate legal and ethical practices are employed and thoroughly documented according to the laws and policies of the respective country and institution.
* The Subject (family member/legal representative) is willing to participate in this trial for the duration of the implanted EVD system and is willing to comply with the protocol requirements.
Exclusion Criteria
* The Subject is pregnant or lactating.
* The Subject has a suspected or documented allergy to the materials of the EVD system, including silicone, rifampin and clindamycin.
* The Subject has a positive CSF culture prior to EVD implant.
* The Subject is immunocompromised.
* The Subject requires more than one ventricular catheter concurrently.
* The Subject has had an EVD catheter within the previous 30 days.
* The Subject has sepsis, ventriculitis, meningitis, a skin infection/inflammation at or near the implantation site, an ear infection on either side, or a severe respiratory tract infection that, in the opinion of the Investigator, would most likely compromise the effectiveness of the EVD system.
* The Subject is known to have received systemic antibiotic therapy within a 14-day period preceding screening for inclusion in this trial.
* The Subject has an uncontrolled coagulopathy or any other known bleeding diathesis.
* The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this trial.
* The Subject is a prisoner.
18 Years
ALL
No
Sponsors
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Codman & Shurtleff
INDUSTRY
Responsible Party
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Principal Investigators
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J. Thomas Megerian, MD, PhD
Role: STUDY_DIRECTOR
Unaffilliated
Locations
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Los Angeles, California, United States
Gainesville, Florida, United States
Syracuse, New York, United States
Hershey, Pennsylvania, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Sherbrooke, Quebec, Canada
Tiantan Hospital
Beijing, , China
Xuan Wu Hospital
Beijing, , China
Angers, , France
Lille, , France
Paris, , France
Prince of Wales Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Oslo, , Norway
National Neuroscience Institute
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Bristol, , United Kingdom
Leeds, , United Kingdom
Salford, , United Kingdom
Countries
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References
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Codman in house testing reports, TR2213 and PVER99-133 Addendum
Bayston R. Hydrocephalus Shunt Infections. Chapman and Hall Medical, London, 1989, p. 23.
Bayston R, Grove N, Siegel J, Lawellin D, Barsham S. Prevention of hydrocephalus shunt catheter colonisation in vitro by impregnation with antimicrobials. J Neurol Neurosurg Psychiatry. 1989 May;52(5):605-9. doi: 10.1136/jnnp.52.5.605.
Bayston R, Lambert E. Duration of protective activity of cerebrospinal fluid shunt catheters impregnated with antimicrobial agents to prevent bacterial catheter-related infection. J Neurosurg. 1997 Aug;87(2):247-51. doi: 10.3171/jns.1997.87.2.0247.
Govender ST, Nathoo N, van Dellen JR. Evaluation of an antibiotic-impregnated shunt system for the treatment of hydrocephalus. J Neurosurg. 2003 Nov;99(5):831-9. doi: 10.3171/jns.2003.99.5.0831.
Lozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. doi: 10.1097/00006123-200207000-00024.
Schierholz J, Jansen B, Jaenicke L, Pulverer G. In-vitro efficacy of an antibiotic releasing silicone ventricle catheter to prevent shunt infection. Biomaterials. 1994 Oct;15(12):996-1000. doi: 10.1016/0142-9612(94)90080-9.
Zabramski JM, Whiting D, Darouiche RO, Horner TG, Olson J, Robertson C, Hamilton AJ. Efficacy of antimicrobial-impregnated external ventricular drain catheters: a prospective, randomized, controlled trial. J Neurosurg. 2003 Apr;98(4):725-30. doi: 10.3171/jns.2003.98.4.0725.
Other Identifiers
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BAC-IN02-002
Identifier Type: -
Identifier Source: org_study_id